Observations
Health IT must be able to electronically perform the following capabilities under all applicable standards and implementation specifications:
Proposed §170.315(b) Care Coordination (1) TRANSITIONS OF CARE
(i) SEND AND RECEIVE VIA EDGE PROTOCOL. Technology must be able to:
(A) Send transitions of care/referral summaries through a method that conforms to the standard specified at §170.202(d); and
(B) Receive transitions of care/referral summaries through a method that conforms to the standard specified at §170.202(d) from a service that has implemented the standard specified in §170.202(a).
(C) XDM processing. Receive and make available the contents of a XDM package formatted in accordance with the standard adopted in §
170.205(p)(1) if the technology is also being certified using an SMTP-based edge protocol.
(ii) VALIDATE AND DISPLAY.
(A) Technology must demonstrate its ability to detect valid and invalid transition of care/referral summaries received and formatted in accordance with both of the standards specified in § 170.205(a)(3) and (4). This includes the ability to:
(1) Parse each of the document types formatted according to the following document templates: CCD; Consultation Note; History and Physical;
Progress Note; Care Plan; Transfer Summary; Referral Note, and Discharge Summary.
(2) Detect errors in corresponding “document-templates,” “section-templates,” and “entry“section-templates,” including invalid vocabulary standards and codes not specified in either of the standards adopted in
§170.205(a)(3) and (4);
(3) Identify valid document-templates and process the data elements required in the corresponding section-templates and entry-templates from either of the standards adopted in §170.205(a)(3) and (4);
(4) Correctly interpret empty sections and null combinations; and (5) Record errors encountered and allow for a user to be notified of or
• Revised certification criterion for both settings
• Base EHR—Included
• To address “bilateral asynchronous cutover,” technology must demonstrate conformance and capability to create and parse both versions of the Consolidated CDA standard:
o HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Release 2.0 [C-CDA 2.0]
o HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, (US Realm) Draft Standard for Trial Use July 2012, DSTU Release 1.1 [C-CDA 1.1]
o ONC seeks comment on alternative approaches for the creation of C-CDA documents
• Technology must detect valid and invalid C-CDA documents, including document, section, and entry level templates for data elements specified in the criterion to demonstrate baseline capability to prepare necessary data for clinical information reconciliation and incorporation. This includes the abilities to:
o Detect invalid C-CDA documents (i.e., data that does not conform to either C-CDA 1.1 or 2.0); invalid vocabularies and codes (i.e., those codes not specified in either C-CDA 1.1 or 2.0)
o Identify valid C-CDA document templates and process required data elements, sections, and entries
o Correctly interpret empty sections and nullFlavor combinations
• Technology must support the “IHE XDR profile for Limited Metadata Document Sources” edge protocol or an SMTP-focused edge protocol (SMTP alone or SMTP in combination with either IMAP4 or POP3).
o For a Health IT Module that is also being certified to the SMTP-based edge, the Module must demonstrate the ability to accept and process an XDM package it receives.
• Includes an updated Common Clinical Data Set with references to new and
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Observations
review the errors produced.
(B) Technology must be able to display in human readable format the data included in transition of care/referral summaries received and formatted according to the standards specified in §170.205(a)(3) and (4).
(C) SECTION VIEWS. Allow for individual display each additional section or sections (and the accompanying document header information) that were included in a transition of care/referral summary received and formatted in accordance with either of the standards adopted in §170.205(a)(3) and (4).
(iii) CREATE. (A) Enable a user to create a transition of care/referral summary:
(1) Formatted according to the standards adopted at §170.205(a)(3);
(2) Formatted according to the standards adopted at §170.205(a)(4); and (3) Includes, at a minimum, the Common Clinical Data Set and the following data expressed, where applicable, according to the specified standard(s):
(i) ENCOUNTER DIAGNOSES. The standard specified in §170.207(i) or, at a minimum, the version of the standard specified §170.207(a)(4);
(ii) Cognitive status;
(iii) Functional status;
(iv) Ambulatory setting only. The reason for referral; and referring or transitioning provider's name and office contact information; and (v) Inpatient setting only. Discharge instructions.
(B) PATIENT MATCHING DATA QUALITY. Technology must be capable of creating a transition of care/referral summary that includes the following data and, where applicable, represent such data according to the additional constraints specified below:
(1) DATA. First name, last name, maiden name, middle name (including middle initial), suffix, date of birth, place of birth, current address, historical address, phone number, and sex.
(2) CONSTRAINT. Represent last/family name according to the CAQH Phase II Core 258: Eligibility and Benefits 270/271 Normalizing Patient Last Name Rule version 2.1.0.
(3) CONSTRAINT. Represent suffix according to the CAQH Phase II Core 258: Eligibility and Benefits 270/271 Normalizing Patient Last Name Rule version 2.1.0 (JR, SR, I, II, III, IV, V, RN, MD, PHD, ESQ). If no suffix exists, the field should be entered as null.
updated vocabulary standards code sets
• Transition of care/referral summary must include encounter diagnoses using either o September 2014 Release of the U.S. Edition of SNOMED CT®, or o ICD-10
• Includes a limited set of standardized data for the “create” portion of the criterion;
ONC clarifies that the data must be captured when it is exchanged (not upon data entry)
• ONC also seeks comment on:
o The proposed approach for patient matching;
o Whether if should adopt a separate health IT certification criterion for the capability to create a summary record formatted to the C-CDA Release 2.0 with or without the ability to meet the requirements of the Common Clinical Data Set definition; and
o With respect to C-CDA data provenance—
The maturity and appropriateness of the implementation guide HL7 IG for CDA Release 2: Data Provenance, Release 1 (US Realm) (DSTU) to tag health information with provenance metadata in connection with C-CDA; and
The usefulness of the IG in connection with certification criteria, such as ToC and View, Download, and Transmit to a 3rd Party (VDT).
• Gap certification status: Not Eligible
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(4) CONSTRAINT. Represent the year, month and date of birth as required fields while hour, minute and second should be optional fields. If hour, minute and second are provided then either time zone offset should be included unless place of birth (city, region, country) is provided; in latter local time is assumed. If date of birth is unknown, the field should be marked as null.
(5) CONSTRAINT. Represent phone number (home, business, cell) in the ITU format specified in ITU-T E.123 and ITU-T E.164. If multiple phone numbers are present, all should be included.
(6) CONSTRAINT. Represent sex in accordance with the standard adopted at
§170.207(n)(1).
(2) Clinical information reconciliation and incorporation.
(i) GENERAL REQUIREMENTS. Clauses (ii) and (iii) below must be completed based on the receipt of a transition of care/referral summary formatted in accordance with the standard adopted in §170.205(a)(3) as well as separately to the standard adopted in §170.205(a)(4) using the Continuity of Care
Document, Discharge Summary Document and Referral Summary document templates.
(ii) CORRECT PATIENT. Upon receipt of a transition of care/referral summary formatted according to either of the standards adopted at §170.205(a)(3) or (4), technology must be able to demonstrate that the transition of care/referral summary received is or can be properly matched to the correct patient.
(iii) RECONCILIATION. Enable a user to reconcile the data that represent a patient's active medication list, medication allergy list, and problem list as follows. For each list type:
(A) Simultaneously display (i.e., in a single view) the data from at least two sources in a manner that allows a user to view the data and their attributes, which must include, at a minimum, the source and last modification date;
(B) Enable a user to create a single reconciled list of medications, medication allergies, or problems;
(C) Enable a user to review and validate the accuracy of a final set of data;
and
(D) Upon a user's confirmation, automatically update the list, and incorporate the following data expressed according to the specified standard(s):
• Revised certification criterion.
• Testing would include ability to incorporate valid C-CDAs with variations of data elements to be reconciled; C-CDA must be created based on reconciliation and incorporation process in order to validate incorporation results
• Technology must be able to reconcile problem, medication, and medication allergy data from valid C-CDAs (both Release 1.1. and 2.0) with variations of data elements to be reconciled and then generate a conformant C-CDA document based on the reconciled information.
• Gap certification status: Not Eligible
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Observations
(1) MEDICATIONS. At a minimum, the version of the standard specified in
§170.207(d)(2);
(2) PROBLEMS. At a minimum, the version of the standard specified in
§170.207(a)(3);
(3) MEDICATION ALLERGIES. At a minimum, the version of the standard specified in §170.207(d)(2).
(iv) SYSTEM VERIFICATION. Based on the data reconciled and incorporated, the technology must be able to create a file formatted according to the standard adopted at § 170.205(a)(4) using the Continuity of Care Document document template.
(3) ELECTRONIC PRESCRIBING
(i) Enable a user to prescribe, send, and respond to prescription-related transactions for electronic transmission in accordance with the standard specified at §170.205(b)(2), and, at a minimum, the version of the standard specified in §170.207(d)(3), as follows:
(A) Create new prescriptions (NEWRX);
(B) Change prescriptions (RXCHG, CHGRES);
(C) Cancel prescriptions (CANRX, CANRES);
(D) Refill prescriptions (REFREQ, REFRES);
(E) Receive fill status notifications (RXFILL); and
(F) Request and receive medication history information (RXHREQ, RXHRES).
(ii) Enable a user to enter, receive, and transmit structured and codified prescribing instructions for the transactions listed in clause (i) above for electronic transmission in accordance with the standard specified at
§170.205(b)(2) and, at a minimum, for at least the following component composites:
(A) Repeating Sig; (B) Code System; (C) Sig Free Text String; (D) Dose; (E) Dose Calculation; (F) Vehicle; (G) Route of Administration; (H) Site of Administration; (I) Sig Timing; (J) Duration; (K) Maximum Dose Restriction;
(L) Indication; and (M) Stop.
(iii) Technology must limit a user’s ability to prescribe all medications in only the metric standard.
• Revised certification criterion
• Includes additional NCPDP SCRIPT v.10.6 transactions in addition to New Prescription transaction for testing and certification (see Table 3 of the proposed rule)
o ONC seeks comment on the proposed transactions and segments; on other NCPDP SCRIPT v.10.6 transactions that should be considered; and what factors to consider for end-to-end prescriber-to-receiver testing
• Adopts the February 2, 2015 version of RxNorm as the baseline minimum standards code set for coding medications
• Technology must enable user to enter, receive and transmit codified Sig
instructions (i.e., free text format e-prescribing with medication name, dose, route of administration, frequency of administration and other special instructions)
o Structured format in accordance with NCPDP Structured and Codified Sig Format Implementation Guide v1.2 embedded within NCPDP SCRIPT v10.6
o Applies to New, Change, Refill, and Cancel Prescription; Fill Status; and Medication History
o Health IT Module must include all structured Sig segment components enumerated in NCPDP SCRIPT v10.6
o ONC welcomes comment on this proposal
• Health IT Module:
o Would limit user’s ability to e-prescribe medications only to the metric standard; and
o Must always be capable of—
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Observations
(iv) Technology must always insert leading zeroes before the decimal point for amounts less than one and must not allow trailing zeroes after a decimal point when a user prescribes medications.
Inserting leading zeros before the decimal point for amounts less than one; and
Precluding trailing zeros after the decimal point.
o ONC welcomes comments, including on the feasibility of the proposal
• Gap certification status: Not Eligible (4)INCORPORATE LABORATORY TESTS AND VALUES/RESULTS
(i) RECEIVE RESULTS.
(A) Ambulatory setting only:
(1) Receive and incorporate clinical laboratory tests and values/results in accordance with the content exchange standard specified in §170.205(j)(2), and, at a minimum, LOINC® vocabulary standard specified in
§170.207(c)(3).
(2) Display the tests and values/results received in human readable format.
(B) Inpatient setting only: Receive clinical laboratory tests and
values/results in a structured format and display such tests and values/results in human readable format.
(ii) Display the test report information:
(A) Specified in 42 CFR 493.1291(a)(1) through (a)(3) and (c)(1) through (c)(7);
(B) Related to reference intervals or normal values as specified in 42 CFR 493.1291(d);
(C) For alerts and delays as specified in 42 CFR 493.1291(g) and (h); and (D) For corrected reports as specified in 42 CFR 493.1291(k)(2).
(iii) Attribute, associate, or link a laboratory test and value/result with a laboratory order or patient record.
• Revised certification criterion
• For the ambulatory setting, adopts the updated version of the implementation guide: HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, DSTU Release 2 (US Realm) (LRI Release 2)
• Provides more specific requirements for how technology must electronically display information in a test report
• Adopts the updated version of LOINC® vocabulary standard (version 2.50)
• ONC seeks comment on EHR-S Functional Requirements of LRI IG/Testing and Certification requirements (HL7 EHR-S Functional Requirements for the V2.5.1 Implementation Guide: S&I Framework Lab Results Interface R2, Release 1, US Realm, Draft Standard for Trial Use, Release 1 (“EHR-S IG”)) for the following:
o The clarity and completeness of EHR-S IG in describing requirements for receipt and incorporation of lab results to measure conformity of a Health IT Module to LRI Release 2;
o How Modules should be tested and certified consistently and uniformly for incorporation of lab results data; and
o Which specific capabilities included in EHR-S IG should be part of testing and certification for this criterion.
• Gap certification status: Not Eligible
(5) TRANSMISSION OF LABORATORY TESTS REPORTS
Technology must be able to electronically create laboratory test reports for electronic transmission in accordance with:
(i) The content exchange standard specified in §170.205(j)(2), and,
(ii) At a minimum, LOINC® vocabulary standard specified in §170.207(c)(3).
• Revised certification criterion
• Adopts HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Draft Standard for Trial Use, Release 2, US Realm (“LRI Release 2”)
• Adopts the updated version of LOINC® vocabulary standard (version 2.50)
• Gap certification status: Not Eligible
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Observations
(6) DATA PORTABILITY
(i) GENERAL REQUIREMENTS FOR EXPORT SUMMARY CONFIGURATION. A user must be able to set the following configuration options when using technology to create an export summary or set of export summaries for patients whose information is stored in the technology. A user must be able to execute these capabilities at any time the user chooses and without subsequent developer assistance to operate.
(ii) DOCUMENT CREATION CONFIGURATION
(A) DOCUMENT-TEMPLATE TYPES. A user must be able to configure the technology to create an export summary or export summaries formatted according to the standard adopted at §170.205(a)(4) for any of the following document-template types.
(1) GENERALLY APPLICABLE. CCD; Consultation Note; History and Physical; Progress Note; Care Plan; Transfer Summary; and Referral Note.
(2) INPATIENT SETTING ONLY. Discharge Summary.
(B) For any document-template selected the technology must be able to include, at a minimum, the Common Clinical Data Set and the following data expressed, where applicable, according to the specified standard(s):
(1) ENCOUNTER DIAGNOSES. The vocabulary standard specified in
§170.207(i) or, at a minimum, the version of the standard at
§170.207(a)(4);
(2) COGNITIVE STATUS; (3) FUNCTIONAL STATUS;
(4) AMBULATORY SETTING ONLY. The reason for referral; and referring or transitioning provider's name and office contact information; and (5) INPATIENT SETTING ONLY. Discharge instructions.
(C) Use of the “unstructured document” document-level template is prohibited for compliance with the standard adopted at §170.205(a)(4)).
(iii) TIMEFRAME CONFIGURATION. A user must be able to configure the technology to set the time period within which data would be used to create the export summary or summaries. This must include the ability to enter in a start and end date range as well as the ability to set a date at least three years into the past from the current date.
• Revised certification criterion
• Base EHR—Included
• ONC reports both developer “confusion about scope” and providers
dissatisfaction with the technology products; proposes major revisions and greater specificity and emphasizes the following:
o Capability must be user-focused and user driven
o User must be able to configure the Health IT Module to create an export summary for a given patient (or a set of export summaries for as many patients selected).
o Export summaries must be able to create according to the following document templates in C-CDA R2.0: CCD; Consultation Note; History and Physical; Progress Note; Care Plan; Transfer Summary; and Referral Note.
o Requires a minimum data set to be included in export summaries o User must be able to configure the technology to
Set the time period within which data is used to create the export summary; and
Create an export summary based on relative date or time, specific date or time, and when user signs an order or note o All these capabilities must be configured and executed by the user
without help from the developer personnel or the need to ask for developer action
• ONC proposes to adopt two new certification criteria (see paragraphs (7) and (8) immediately below) to separately track (i.e., segment) individually identifiable health information protected by state or federal privacy laws more restrictive than the HIPAA Privacy Rule (one criterion each for send and receipt of the data)
• Gap certification status: Not Eligible
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(iv) EVENT CONFIGURATION. A user must be able to configure the technology to create an export summary or summaries based on the following user selected events:
(A) A relative date or time (e.g., the first of every month);
(B) A specific date or time (e.g., on 10/24/2015); and (C) When a user signs a note or an order.
(v) LOCATION CONFIGURATION. A user must be able to configure and set the storage location to which the export summary or export summaries are intended to be saved.
(7) DATA SEGMENTATION FOR PRIVACY – SEND
Technology must enable a user to create a summary record formatted in accordance with each of the standards adopted in §170.205(a)(3) and (4) that is tagged as restricted and subject to restrictions on re-disclosure according to the standard adopted in §170.205(o)(1).
• New certification criterion
• Intended to permit users to comply with varying privacy law requirements at the state and federal level beyond the HIPAA Privacy Rule in an electronic
environment
o Applies security labels (privacy metadata) so appropriate access control decisions may be made for downstream use, access or disclosure for specially protected data
o Metadata applied in layers (i.e., at the header, section or entry levels of a C-CDA document)
• Module must be able to send documents using document level tagging
• Content exchange standards: both versions of the Consolidated CDA standard:
o HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Release 2.0 [C-CDA 2.0]
o HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, (US Realm) Draft Standard for Trial Use July 2012, DSTU Release 1.1 [C-CDA 1.1]
• Restrictions on redisclosure context exchange standard: HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1
• ONC notes that the application of the privacy standard at the document level is an initial step
• Gap certification status: Not Eligible
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(8) DATA SEGMENTATION FOR PRIVACY – RECEIVE Technology must enable a user to:
(i) Receive a summary record that is tagged as restricted and subject to restrictions on redisclosure according to the standard adopted in
§170.205(o)(1);
(ii) Apply document-level tagging and sequester the document from other documents received; and
(iii) View the restricted document (or data), without incorporating the document (or data).
• New certification criterion
• Module must be able to receive privacy data in accordance with HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1
• Recipient must be able to receive, recognize, and view documents with privacy metadata tagging indicating certain restrictions with the document sequestered from other health IT data
• Gap certification status: Not Eligible
(9) CARE PLAN
Technology must enable a user to record, change, access, create, and receive care plan information in accordance with the Care Plan document template in the standard adopted in §170.205(a)(4).
• New certification criterion
• C-CDA Release 2.0 Templates for Clinical Notes includes a Care Plan document template which provides a structured for documenting information such as goals, health concerns, health status evaluations and outcomes, and interventions
o Is distinct from Plan of Care Section in previous versions of C-CDA
• Criterion focuses only on user's ability to record, change, access, create, and receive care plan information
• ONC seeks comment on whether certain optional “Sections” in the template
• ONC seeks comment on whether certain optional “Sections” in the template